FDA Related News

Human Drugs

Neurotech Review Extension on Retinal Disease BLA

FDA extends its review of a Neurotech Pharmaceuticals BLA for NT-501 (revakinagene taroretcel) as a treatment for macular telangiectasia Type 2.

Human Drugs

Public Citizen Blasts Potential Drug Approval Change

Public Citizen preemptively criticizes expected 2025 legislation to authorize FDA to approve drugs for rare diseases based on substantial evidence rat...

Federal Register

FDA Ban on Phenylephrine in Nasal Decongestants

Federal Register notice: FDA issues a proposed administrative order to remove orally administered phenylephrine in OTC nasal decongestants.

Medical Devices

Poor Training Found in Lab Inspections

FDA cites a lack of adequate training in FY 2023 Good Laboratory Practice inspection form FDA-483s.

Medical Devices

FDA Approves J&J Varipulse Platform

FDA approves the J&J Varipulse pulsed field ablation platform to treat atrial fibrillation.

Human Drugs

Sarepta Scraps Next-Gen Duchenne Drug

Based on safety concerns, Sarepta says it is discontinuing the development of SRP-5051 (vesleteplirsen) for treating patients with Duchenne muscular d...

Human Drugs

Model-Informed Drug Development Comments

Four stakeholders respond to an FDA request for comments on guidance development and engaging with stakeholders on model-informed drug development.

Medical Devices

Electa Instrument Recalls Biopsy Needle Kits

Elekta Instrument AB recalls (Class 1) its Elekta Disposable Biopsy Needle Kit for the Leksell Stereotactic System due to microscopic debris found on ...

FDA General

How Soon Will Trump Nominate Next FDA Head?

FDA watchers need patience as they wait to see who president-elect Donald Trump chooses to nominate as the next FDA commissioner.

IRB Violations Seen in FDA-483s

FDA identifies four trends in IRB violations from FDA-483s issued in FY 2023.